New Delhi: India’s patent protection regime will be a key issue in next month’s strategic dialogue with the US, against the backdrop of a landmark ruling by the Indian patent office allowing Natco Pharma Ltd to make and sell a copy of German drug maker Bayer AG’s patented cancer treatment Nexavar.
This month, the US Trade Representative (USTR) put India on a priority watch list for allegedly providing insufficient protection and enforcement of intellectual property rights. The USTR report urged India “to continue to work to streamline its patent opposition proceedings”.
It added, “the United States will closely monitor developments concerning compulsory licensing of patents in India following the broad interpretation of Indian law in a recent decision by the Controller General of Patents, while also bearing in mind the Doha Declaration on TRIPS and Public Health.”
TRIPS is short for trade-related intellectual property rights.
In March, India’s Controller General of Patents passed an order allowing Hyderabad-based Natco Pharma to manufacture and market a generic version of Nexavar—the first time an Indian firm was granted a so-called compulsory licence, which permits a generic drug producer to make and sell its version of a patented drug without the consent of the patent holder.
The drug, patented by Bayer in India in 2008, is used in the treatment of liver and kidney cancer, and costs Rs 2.8 lakh for a month’s dosage. The patent office stipulated that Natco price the drug at Rs 8,880 for a pack of 120 tablets (a month’s dosage) and pay 6% of net sales as royalty to Bayer.
Soon after the verdict, US commerce secretary John Bryson, who was visiting India in March, told commerce and industry minister Anand Sharma that the US was “deeply concerned” over the issue, which he said may weaken the global patent regime under TRIPS. Bayer has appealed against the patent office’s ruling.
A senior official in the health ministry characterized the flap over the Nexavar case as a “trade war” between Indian drug companies and multinational pharmaceutical firms.
“The Indian government has put its weight behind Indian drug companies so far and will continue to resist pressure to agree to TRIPS plus,” said this person who did not want to be identified. “There is a sustained campaign to call India generic drugs substandard. If any trading partner feels that India has violated the trade agreement, the right platform to bring up the issue is the World Trade Organization (WTO) instead of arm-twisting in bilateral meets.”
TRIPS plus is a reference to provisions that are in addition to the patent requirements of WTO.
Next month’s dialogue in the US takes place ahead of the July hearing in the Supreme Court on an appeal by Swiss drug maker Novartis AG seeking an extension of its patent on the cancer drug Glivec. Novartis has argued that its patent on the drug should be extended as it has increased its efficacy by 30%.
The compulsory licence granted to Natco Pharma was welcomed by some developing countries and healthcare groups as a step towards making costly cancer therapies accessible to the poor. International drug makers said the move would kill the incentive for drug research and didn’t respect intellectual property rights.
Pressures on the trade front have only grown in the years since the creation of WTO in 1995, said public health activist and coordinator of the All India Drug Action Network (AIDAN) Mira Shiva. “Multinational drug companies are going to insist on stronger and stronger IPR because the Indian generic industry is a threat to them,” Shiva said. “The report (by USTR) is part of that continued pressure tactic.”